ANGLE PLC (LON:AGL) still expects to make a US regulatory submission for its Parsortix cancer-detecting system in or around October, offering the chance that it could be given the green light early next year.
Announcing results for the year to 30 April, the AIM-listed company confirmed that the submission process remained “on track” as a clinical trial on 400 women showed that Parsortix captured and harvested cancer cells from the blood of a significant proportion of metastatic breast cancer patients.
Discussions with US Food & Drug Administration recently identified additional study experiments that will be needed to support FDA clearance, which ANGLE said have “minimal cost” and are expected to be completed to allow FDA submission in “early Q4” of the calendar year.
ANGLE finished its trading year with £11mln of cash and topped this up with a net £16.9mln fundraising post-period end.
Full-year results to were in line with its trading update at the time of its recent placing in June, with revenue and grant income up 25% to £853,000, with an adjusted net loss of £8.6mln compared to £7.2mln the previous year, reflecting clinical study costs for Parsortix and costs associated with the acquisition of Axela’s Ziplex molecular analysis platform the previous year.
“We expect that the next 12 months will see several key milestones for the company,” said chairman Garth Selvey, “with the prospect of FDA clearance in early calender year 2020, and we look forward to updating the market as we progress the FDA clearance process as well as our ovarian cancer clinical verification study.”
Broker FinnCap noted that, together with the ovarian cancer triage test that is due to finish a final verification study in the first quarter of 2020, "ANGLE is poised to commercialise its sample-to-answer Parsortix HyCEAD Ziplex solution via its own service lab and external partnerships in both research and clinical settings".